Status:
RECRUITING
Implementing Low-Barrier HCV Treatment in a Jail Setting
Lead Sponsor:
Lifespan
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HEPATITIS C (HCV)
Incarceration
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study fo...
Detailed Description
This is a hybrid effectiveness-implementation pilot study testing a simplified model of hepatitis C virus (HCV) treatment called MINMON-J, based on the successful "minimal monitoring" approach used in...
Eligibility Criteria
Inclusion
- Incarcerated individual at RIDOC
- Age ≥ 18 years
- Awaiting trial (i.e., not sentenced)
- English speaking
- Diagnosis of active HCV (HCV RNA \>1000 IU/mL within 90 days prior to study entry)
- Treatment-naïve for current HCV infection
- No cirrhosis (FIB-4 Score \<3.25 within 90 days prior to study entry)
- Self-report of injection drug use
- Ability and willingness to be contacted after jail release
- Verbal commitment to continue medication after discharge
- Desire to receive Sofosbuvir/Velpatasvir (Epclusa)
Exclusion
- Cirrhosis (FIB-4 Score \>3.25 within 90 days prior to study entry and/or clinical signs of cirrhosis)
- Positive for Hepatitis B surface antigen
- Actively pregnant or breastfeeding
- Known allergy/sensitivity to study drug components
- Acute or serious illness requiring hospitalization at enrollment
- Documented severe persistent mental illness (SPMI) by RIDOC
- Any clinical history of hepatic decompensation (e.g., ascites, SBP, HE, HRS, variceal bleeding)
- HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days
Key Trial Info
Start Date :
June 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06953479
Start Date
June 11 2025
End Date
August 1 2027
Last Update
July 10 2025
Active Locations (1)
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1
Rhode Island Department of Corrections
Cranston, Rhode Island, United States, 02920